TPLC - Total Product Life Cycle

• Device: agent, tooth bonding, resin
• Regulation Description: Resin tooth bonding agent.
• Product Code: KLE
• Regulation Number: 872.3200
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	2
DENMAT HOLDING, LLC
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	4
DMP DENTAL INDUSTRY S.A.
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
KERR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KURARAY NORITAKE DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIAONING UPCERA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICLUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
META BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIER DENTAL PRODUCTS COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE ORTHODONTIC PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	4
ROUNDING THIRD, LLC
	SUBSTANTIALLY EQUIVALENT	1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITÄTEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SAREMCO DENTAL AG
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SINO-DENTEX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPIDENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Unitek Corporation	II	Jan-02-2025
2	Ultradent Products, Inc.	II	Jul-12-2022